DESCRIPTION
id: c4b965a8-22ba-49e3-b61c-edbd89d079f2
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Clonazepam, a benzodiazepine, is available as scored tablets debossed with “1” and “2” containing 0.5 mg of clonazepam and unscored tablets debossed with “C 1” on 1 mg tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of clonazepam. Each tablet contains anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 Lake.
Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula:
CONTRAINDICATIONS
id: f65bc920-2fd8-48fd-b23e-c7d52e27bfd9
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Clonazepam should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
ADVERSE REACTIONS
id: 5b15f3d8-0f02-4aeb-8ed4-55efa97cbc99
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.
DOSAGE AND ADMINISTRATION
id: f07f66c5-9364-41db-8b86-7f5a79396759
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Clonazepam is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.
HOW SUPPLIED
id: 360b2217-a47d-45b5-a6f6-988a97f83dc7
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows:
Bottles of 30 NDC 63187-603-30
Bottles of 60 NDC 63187-603-60
Bottles of 90 NDC 63187-603-90
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
Manufactured For:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.
Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. : 457, 458,
Village – Matoda,
Bavla Road, Ta.- Sanand,
Dist.- Ahmedabad – 382 210.
India.
Repackaged By:
Proficient Rx LP
Thousand Oaks, CA 91320
10 7744 1 626035
Issued October, 2010.
PRINCIPAL DISPLAY PANEL – 0.5 mg
id: cb08e8f9-aca6-4eda-bfe9-428b0c2a4b44
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
NDC 63187-603-60
CLONAZEPAM CIV
TABLETS, USP
0.5 mg
Rx Only
Pharmacist: Must be dispensed with Medication Guide.
60 TABLETS
accord
